510(k) Report

Devices descending from K133200

10 later devices reach Stalif C (R) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—